BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Marketing authorisations based on studies performed at the Semler Research Center (SRC) Private Ltd. company in India: suspension of marketing authorisations

Active substance: atovaquone/proguanil hydrochloride | celecoxib | eprosartan | pregabalin | saquinavir

15.02.2023 - Note

No more medicinal products are authorised in Germany that were based on studies conducted by the Semler Research Center (SRC) in India. The risk assessment procedure for medicinal products based on studies by this company is therefore no longer relevant for medicinal products authorised in Germany.

11.05.2022 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Federal Institute for Drugs and Medical Devices (BfArM) has extended the suspension of the marketing authorisations, which were based on studies by the company Semler Research Center (SRC) in India, by decision of 04.05.2022.

17.06.2020 - Notice within the graduated plan procedure ("Stufenplanverfahren")

The Federal Institute for Drugs and Medical Devices (BfArM) has provisionally ordered the suspension of further generic drug approvals based on studies by the company Semler Research Center (SRC) in India.

09.08.2016 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In a notice dated 8 August 2016, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled a provisional suspension of the marketing authorisations of several generic medicinal products.

Further information

Details on the procedure can be found on the website of the European Medicines Agency (EMA):

To the risk assessment procedure (available in German only)

Use of cookies

Cookies help us to provide our services. By using our website you agree that we can use cookies. Read more about our Privacy Policy and visit the following link: Privacy Policy (only in German)

OK